Cleared Blood Glucose Monitor Systems Not Always Accurate
Cleared BGMs do not always meet the level of analytical accuracy currently required for regulatory clearance.
HealthDay News — One in three commercially available blood glucose monitor systems (BGMs) meet a predefined accuracy standard, according to research published online June 13 in Diabetes Care.
David C. Klonoff, M.D., from the Diabetes Research Institute in San Mateo, Calif., and colleagues recruited 1,035 subjects to have a capillary blood glucose level measured on six different systems and a reference capillary sample prepared for plasma testing at a reference laboratory. The products, which were obtained from consumer outlets, were tested in three triple-blinded studies. For each of the three studies, each of the three participating clinical sites tested a different set of six systems. A BGM was tested on 115 subjects, on average, in each study. In each study, the proportion of compliant readings was compared against a predetermined accuracy standard, which was similar to, but more lenient than, current regulatory standards.
The researchers found that almost identical BGM rankings were produced with the different accuracy metrics. The predetermined accuracy standard was met by six of the 18 systems in all three studies, five systems in two studies, and three systems in one study. The accuracy standard was not met in any of the three studies by four BGMs.
"Cleared BGMs do not always meet the level of analytical accuracy currently required for regulatory clearance," the authors write. "This information could assist patients, professionals, and payers in choosing products, and regulators in evaluating post-clearance performance."
Several authors disclosed ties to the pharmaceutical industry, including Abbott Diabetes Care, which funded the study.